HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Shots: The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the…

ByRidhi RastogiJuly 16, 2026

NEWS

Eli Lilly’s Retatrutide Delivers Significant Improvements in Weight, A1C, Knee Osteoarthritis Pain, and Obstructive Sleep Apnea (OSA)

Shots: In TRIUMPH-1 trial & nested studies in knee osteoarthritis pain & OSA, retatrutide met all 1EPs at 80wks., with weight loss of 25.9% (9mg) & 28.3% (12mg). At 12mg, 65.3% pts achieved a BMI <30 & 33.3% reached BMI <25, while those with BMI ≥35 lost ~85 lbs through 104wks. It also reduced WOMAC…

ByRidhi RastogiJune 8, 2026

NEWS

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Shots: Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance In the RCT (therapy start: M1 vs M7), M12…

ByRidhi RastogiMarch 20, 2026

NEWS

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Shots: The US FDA has granted 510(k) clearance to the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of OSA pts (>66lbs) Kricket PAP device uses KPAP tech to dynamically adjust pressure with each breath, synchronizing with pts’ natural respiration to reduce unnecessary pressure, improve comfort & tolerance, & offering…

ByRidhi RastogiDecember 18, 2025

NEWS

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

Shots: The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated Approval was based on the DREAM trial, which met its 1 & 2EPs, showing a 63.5% AHI responder rate, 71.3% oxygen desaturation index responder rate, & 70.8% median AHI…

ByRidhi RastogiAugust 11, 2025

NEWS

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

ByRidhi RastogiJuly 24, 2025

NEWS

Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapy Trial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory…

ByRidhi RastogiMay 19, 2025

HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Eli Lilly’s Retatrutide Delivers Significant Improvements in Weight, A1C, Knee Osteoarthritis Pain, and Obstructive Sleep Apnea (OSA)

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Contact US

FOLLOW US